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International Clinical Trials

Piece of the Action

According to recent estimates, there are nearly 150,000 active clinical trials taking place in 185 countries across the globe (1). Most of these studies will collect human samples for testing throughout the drug development process.

When properly preserved, these biomaterials allow researchers to conduct a wide range of analyses – helping them to better understand genetic and molecular changes involved in disease progression, and to assess the effectiveness of new drugs and therapeutics in a particular patient population, which can lead to more personalised treatments.

Furthermore, as biomarker development becomes a critical component of drug development, the collection of high-quality, well-annotated samples has become essential to clinical trials and medical research. In fact, a 2010 report by the Tufts Center for the Study of Drug Development noted that half of all clinical trials collect DNA from participants to help find biomarkers that correlate with a drug’s effectiveness or safety (2).

Scientific Assets

In addition to the scientific benefits, the value of well-kept samples must be considered from a financial perspective as drug development costs soar into the billions. Due to the inherent value of samples, these materials should be considered scientific assets, and as such, managed with methods that will ensure future medical discovery is not compromised due to lost or degraded samples.

While the scientific and commercial benefits of a well-collected, properly preserved sample biorepository are recognised by researchers worldwide, to date there are no formal regulations that direct the collection and management of clinical trial samples. In the absence of such regulations, standard operating procedures are an ideal tool to establish standardisation for biorepositories and clinical research sites.

Collection and Preparation

Pre-analytical variables account for up to 93 per cent of laboratory errors encountered during the total diagnostic process, and encompass the time from when the researcher orders the assay until the sample is ready for analysis (3).

Often, these variables – including time, temperature and handling procedures – are introduced during the sample collection process, and can significantly impact the molecular integrity of the sample and consequently bias the results of assays and/or biomarker studies. Therefore, an essential component of sample management requires standardised protocols for sample preparation techniques.

Sample collection involves three components: collection of the physical sample; processing of the sample; and recording sample information. Sample information includes: level of patient consent; sample source (for example, study subject); sample characteristics (such as skin tissue plug biopsy); and post-collection processing and storage (placement in freezer, etc).

Inexact sample preparation can lead to sample loss, reprocessing or complicated data interpretation. This bottleneck can delay studies, which ultimately delays a potential drug candidate from going to market. As a result, research protocols should include clear and detailed instructions for collecting, processing and storing samples, such as temperature, centrifuge time and shipping materials.

Transport Logistics

The rising costs, complexity and regulatory challenges caused by the increasingly global nature of clinical studies presents significant challenges for companies seeking to effectively manage and transport samples around the world, which are often temperature sensitive.

Weakness or failure at any point in the cold chain can compromise product integrity, breach security, delay shipments and ultimately result in fi nancial loss or liability. Common issues that can have an impact on sample integrity during transport include:
  • Prolonged delivery delays caused by transportation glitches, security inspections or customs scrutiny
  • Temperature fluctuations inside shipping vehicles
  • Seasonal or climatic differences between the origination and destination site
Sample Understanding

To mitigate risk of material degradation and ensure regulatory compliance, personnel should have a broad understanding of the intricacies involved in transporting samples globally. In fact, the International Air Transport Association requires organisations and individuals that ship or receive biological materials to undergo formal training to meet their standards in packaging, labelling, documentation, declaration, hazard assessment and emergency response.

Depending on the country in which the clinical trial is being conducted, biological specimens and related supplies can be subject to strict import and export requirements. For example, China restricts the exportation of whole blood and genetic materials. In India, sponsors that export human biological specimens for test purposes must apply for export permission from India’s Director General of Foreign Trade (4). As these examples show, export and import of samples can be restricted or even prohibited in some areas of the world.

Organisations can both protect their financial investment and streamline their research with a strategic sample management plan that takes into account best practices for temperature-controlled storage and logistics, regulatory guidelines and audit trails. Familiarity with the requirements and process is critical, and should be considered upfront in the study design.

Good Storage Practices

A sample that has maintained the appropriate storage temperature will yield better results than a sample that has undergone temperature fluctuations due to poor handling or storage practices. However, because it may take years before they are needed for future research, testing or audits, samples must be stored in highly specialised and consistent conditions. To maintain sample integrity for long periods of time, standardised, secure and compliant storage is key.

In the US, to ensure samples are properly handled, transported and stored, the Food and Drug Administration, the Centers for Disease Control and Prevention, and professional organisations – notably the American Association of Tissue Banks, the National Cancer Institute and the International Society for Biological and Environmental Repositories – provide guidelines for Good Storage Practices (GSP). In addition, the College of American Pathologists offers accreditation to biobanks and biorepositories that provide best-in-class biological sample management.

Critical Details

Similar to GxP environments, GSP requires discipline and attention to critical details, such as compliance, data management, contingency planning, and quality and risk management. However, the guiding principles of GSP mandates the standardisation of sample handling and management processes to ensure samples are prepared and stored in consistent conditions.

Various requirements of GSP include:
  • Secure facilities and robust quality assurance measures to ensure specimens are stored in compliant conditions at all times
  • Qualified staff that have been trained in global sample transportation procedures, including regulatory and customs issues
  • Temperature monitoring of samples around the clock with a comprehensive audit trail and automatic notification system
  • Business continuity plans, backup power and redundant systems to protect sample integrity during emergencies
Advanced Technology

While proper storage and transportation are critical, specimens are useless unless they can be located with their associated data, in a timely fashion. In the past, researchers applied ad hoc tracking systems, such as spreadsheets, to track and plot information associated with biospecimens. Today, the complexity of clinical trial research has rendered these outdated and archaic systems inefficient to handle expanding biospecimen inventories. The ideal system should offer tracking and reporting processes through all stages of a sample’s shipping, handling and storage lifecycle.

There is a growing need by drug discovery and development companies to combine sample inventory data from many biobanks, biorepositories and research sites with resulting data from clinical trials, and to conduct metanalysis of this data to support the development of personalised medicines and biomarkers.

Advanced technology systems are required to support this integration and consolidation of sample inventory and clinical trial data. It is important for research companies to have access to sample management inventory systems that allow for robust tracking and auditing of sample information, while providing the flexibility for sample data to be merged with clinical trial testing results. This allows for improved optimisation for sample assets.

Contingency Planning

Unexpected disasters, such as hurricanes, earthquakes, building fires and equipment failure, can threaten the very existence of a research organisation. To mitigate these risks, they should establish plans that outline the procedures and protocols to alleviate the effects a disaster may have on their sample inventories and research operations.

Implementing redundant measures like a backup power source with regular load tests of equipment is essential to ensure the integrity of samples. Further redundancies, such as duplication of IT systems with off-site placement of servers and data storage – also with appropriate uninterrupted power supply – has to be incorporated into long-term plans. This reduces the risk that samples and the corresponding data might be compromised due to on-site power or server failure.

Many commercial biorepositories can accommodate hundreds of freezers, so adequate and redundant heating, ventilation and air-conditioning is necessary due to the heat generated by electrical equipment. Furthermore, staff should be cross-trained to prepare for handling unexpected events.

Today and Tomorrow

High-quality clinical trial samples could hold the key to understanding the molecular and cellular basis of disease, contribute to advancements in personalised medicine, validate biomarkers and identify novel drug targets. These assets must be managed and stored, with considerations for their significant role in current research but also with an eye towards the future and the value they may hold for potential discovery.

The collection, transport, long-term storage, retrieval and disposal of samples have become vital in ensuring the quality of samples, as well as maximising their usefulness and availability for today’s research initiatives and tomorrow’s research discoveries.

References
1. ClinicalTrials.gov, retrieved 26th August 2013
2. Personalised medicine is playing a growing role in development pipelines, Tufts Center for the Study of Drug Development – Impact Report, November/December 2010, Vol. 12 No. 6
3. Preanalytical variables: Room for improvement, Specimencare. com, retrieved 26th August 2013
4. Eudaric A, Managing clinical logistics for clinical trials in emerging markets, originally published in Journal for Clinical Studies. Visit: www.parexel.com/fi les/4412/7518/6212/sec_ managing_clinical_logistics-65337-1.pdf


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As Chief Operating Officer of BioStorage Technologies, Lori Ball leads the company’s global and domestic operations, including strategic business development, the implementation of global growth strategies and overseeing its North American and European facilities. Lori earned an MBA from Indiana Wesleyan University and a BA in Education from Anderson University, Indiana. She holds Six Sigma Green Belt credentials and has completed Six Sigma Executive and Champion training. Lori is a known industry speaker and an expert on specimen transportation.
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